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The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02796950
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : May 8, 2018
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1 are increased in response to acipimox. The hypothesis is that G protein coupled receptors on enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.

In a controlled, open, randomized experiment, eight healthy, overweight men will be studied on an intervention day, where they receive acipimox, and on a control day. The study day includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a biopsy from adipose tissue.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Acipimox Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Acipimox on GLP-1 Secretion in Healthy Subjects: a Pilot Study
Study Start Date : June 2016
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acipimox
Administration of acipimox 250 mg p.o.
Drug: Acipimox
P.o. administration of 250 mg acipimox
Other Name: Olbetam

No Intervention: Control
No intervention.

Primary Outcome Measures :
  1. Levels of GLP-1 in plasma [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Lipolytic activity in adipose tissue by measuring FFA (free fatty acid) levels [ Time Frame: 9 months ]
  2. Insulin sensitivity by measuring blood glucose after an OGTT [ Time Frame: 5 months ]

Other Outcome Measures:
  1. Insulin secretion by measuring levels of insulin and c-peptid [ Time Frame: 9 months ]
  2. Secretion of the hormones ghrelin, leptin and GIP (gastric inhibitory polypeptide) by measuring hormone levels in plasma [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adult men
  • Healthy
  • BMI 25-35

Exclusion Criteria:

  • Known DM2
  • Receiving hypolipidemic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02796950

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University Hospital of Aarhus
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
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Principal Investigator: Jens Otto L Jørgensen, Professor University of Aarhus

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Responsible Party: University of Aarhus Identifier: NCT02796950    
Other Study ID Numbers: GLP-1-16-02-261-16
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Aarhus:
Insulin secretion
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents